PET/MR Imaging In Patients With Cardiac Sarcoidosis

Cardiac Sarcoidosis Clinical Trial

Official title:

Molecular Imaging in Cardiovascular Disease Using Hybrid Positron Emission Tomography/Magnetic Resonance Imaging (PET/MR): Cardiac Sarcoidosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03705884
• Other study ID #: AC17010
• Status: Completed
• Phase: N/A
• Start date: October 30, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: May 2024
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

PET scanning (positron emission tomography) is a well-established technique used to identify areas of interest within the body. It involves injecting a radioactive tracer which highlights abnormal areas. It has recently been combined with CT (computed tomography) and MRI (magnetic resonance imaging) scanning to more accurately identify abnormalities within the heart. Cardiac sarcoidosis, a condition which causes scarring and inflammation within the heart muscle, is of particular interest.

The study makes use of hybrid PET/MR scanning using a designated scanner which enables PET scanning combined with MRI scanning. This will allow imaging of abnormal areas within the heart in this condition alongside treatment regimens in a way which hasn't been done before. If successful, this imaging method will play a key role in diagnosing, quantifying and monitoring these conditions.

All participants will undergo PET scanning, where a radioactive tracer is injected into a vein before the scan. The radioactive substance only lasts for a short time and is safe, passed out of the body in urine. The scan will be performed twice; once before treatment and once after treatment has been established. A cohort of healthy volunteers will undergo scanning in exactly the same way to enable us to compare the results with hearts of people who don't have cardiac sarcoidosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

Cardiac Sarcoidosis Patients:

• Aged over 40 years

• Completion of informed consent

• Established diagnosis of cardiac sarcoidosis

• Established diagnosis as per HRS recommended diagnostic criteria

Healthy Volunteers:

• Aged over 40

• Completion of informed consent

Exclusion Criteria:

• All participants:

• Inability or unwilling to give informed consent

• Women who are pregnant, breastfeeding or of child-bearing potential (women who have experienced menarche, are pre-menopausal and have not been sterilised) will not be enrolled into the trial.

• Major intercurrent illness with life-expectancy <2 years.

• Renal dysfunction (eGFR less than or equal to 30ml/min/1.73m2)

• Adverse reaction or hypersensitivity to 18F-FDG PET tracer

• NYHA Class IV heart failure

• Patients with atrial fibrillation and poor rate control

• Contraindications to MRI scanning

• Previous history of contrast allergy of adverse reactions (Gadolinium-containing agents)

Related Conditions & MeSH terms

• Cardiac Sarcoidosis
• Sarcoidosis

Intervention

Other:
• 18F-FDG
Hybrid 18F-FDG PET/MR imaging for observational diagnostic purposes.

Drug:
• Prednisolone
Oral course of Prednisolone for treatment of sarcoidosis (patient cohort) or as control (healthy volunteer cohort)

Locations

Country	Name	City	State
United Kingdom	Queen's Medical Research Institute	Edinburgh	Midlothian

Sponsors (1)

Lead Sponsor	Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial 18F-FDG uptake	Quantification of myocardial PET tracer uptake before steroid therapy	Within 1 year
Primary	Myocardial 18F-FDG uptake	Quantification of myocardial PET tracer uptake after steroid therapy	Within 1 year